SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE)
today announced the completion of enrollment for the KarMMa pivotal
study of bb2121, the companies’ lead investigational anti-BCMA CAR T
cell therapy candidate for patients with relapsed and refractory
multiple myeloma. bb2121 is being developed as part of a Co-Development,
Co-Promote and Profit Share Agreement between Celgene and bluebird bio.
“We continue to be excited about bb2121 as a potential first-in-class
BCMA-targeted therapy for patients with multiple myeloma,” said Alise
Reicin, M.D., President, Global Clinical Development for Celgene. “We
would like to thank everyone who enabled this achievement, especially
the patients and caregivers, and we congratulate the physicians and
others involved in the KarMMa study, including our dedicated partners at
bluebird bio. We look forward to seeing the data from this study and are
progressing our broader bb2121 development program as we advance closer
toward delivering this important new option to appropriate patients in
need.”
“We are committed to developing new treatment options to improve the
care of patients with multiple myeloma, and completing enrollment of the
KarMMa study moves us closer to this goal,” said David Davidson, M.D.,
chief medical officer, bluebird bio. “As we advance our clinical studies
of bb2121 in earlier lines of therapy in collaboration with our partners
at Celgene, we remain very grateful to the patients, families and
healthcare providers who have made this program possible.”
KarMMa is a pivotal, open-label, single-arm, multi-center phase 2 study
evaluating the efficacy and safety of bb2121 in patients with relapsed
and refractory multiple myeloma. In November 2017, bb2121 was granted
Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug
Administration and PRIority Medicines (PRIME) eligibility by the
European Medicines Agency. The BTD designation and PRIME eligibility
were based on preliminary clinical data from the phase 1 CRB-401 study.
The FDA action date for the bb2121 NDA is anticipated in 2020. bb2121 is
currently an investigational therapy; safety and efficacy have not yet
been established. bb2121 has not been approved for use by any health
authority.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through
next-generation solutions in protein homeostasis, immuno-oncology,
epigenetics, immunology and neuro-inflammation. For more information,
please visit www.celgene.com.
Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
About bluebird bio, Inc.
With its lentiviral-based gene therapies, T cell immunotherapy expertise
and gene editing capabilities, bluebird bio has built a pipeline with
broad potential application in severe genetic diseases and cancer.
bluebird bio's gene therapy clinical programs include investigational
treatments for cerebral adrenoleukodystrophy, transfusion-dependent
β-thalassemia, also known as β-thalassemia major, and sickle cell
disease.
bluebird bio's oncology pipeline is built upon the company's lentiviral
gene delivery and T cell engineering, with a focus on developing novel T
cell-based immunotherapies, including chimeric antigen receptor (CAR T)
and T cell receptor (TCR) therapies. The company’s lead oncology
programs are anti-BCMA CAR T programs partnered with Celgene.
bluebird bio’s discovery research programs include utilizing
megaTAL/homing endonuclease gene editing technologies with the potential
for use across the company's pipeline.
bluebird bio has operations in Cambridge, Massachusetts; Seattle,
Washington; Durham, North Carolina and Zug, Switzerland.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include those regarding the potential
benefits of, and plans relating to the collaboration between bluebird
bio and Celgene in the development of bb2121; the potential of bb2121 as
a therapeutic drug; and the benefit of each company’s strategic plans
and focus. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “would,” “could,”
“potential,” “possible,” “hope” and similar expressions are intended to
identify forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are subject
to numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from current expectations
and beliefs. For example, there can be no guarantee that any product
candidate will be successfully developed or complete necessary
preclinical and clinical phases, or that development of any of product
candidates will successfully continue, or that marketing approval will
be granted. There can be no guarantee that any positive developments
will result in stock price appreciation. Management's expectations and,
therefore, any forward-looking statements in this press release could
also be affected by risks and uncertainties relating to a number of
other important factors, including: results of clinical trials and
preclinical studies, including subsequent analysis of existing data and
new data received from ongoing and future studies; the content and
timing of decisions made by the U.S. FDA and other regulatory
authorities, investigational review boards at clinical trial sites and
publication review bodies; the ability to obtain and maintain requisite
regulatory approvals and to enroll patients in planned clinical trials;
unplanned cash requirements and expenditures; competitive factors; the
ability to obtain, maintain and enforce patent and other intellectual
property protection for any product candidates; the ability to maintain
key collaborations; and general economic and market conditions. These
and other risks are described in greater detail under the caption "Risk
Factors" included in each company’s public filings with the Securities
and Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and neither company
has any obligation to update any forward-looking statements, whether as
a result of new information, future events or otherwise, except as may
be required by law.
Hyperlinks are provided as a convenience and for informational
purposes only. Neither Celgene nor bluebird bio bears responsibility for
the security or content of external websites or websites outside of
their respective control.
All registered trademarks are owned by Celgene Corporation.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181127005268/en/
For Celgene:
Investors:
Patrick Flanigan, 908-673-9969
pflanigan@celgene.com
or
Media:
Greg
Geissman, 908-673-9854
ggeissman@celgene.com
For bluebird bio
Investors:
Elizabeth Pingpank, 617-914-8736
epingpank@bluebirdbio.com
or
Media:
Catherine
Falcetti, 617-583-3411
cfalcetti@bluebirdbio.com
Source: Celgene Corporation